Does Endoscope Position Detecting Unit Facilitate a Complete Colonoscopy Examination
UPD-3
1 other identifier
interventional
870
1 country
2
Brief Summary
As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more and more screening colonoscopies are now being performed for prevention or early detection of this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential to make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate is highly variable and dependent on individual experience. Colonic looping is the commonest cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological imaging technique to provide real time, three-dimensional image and position of the colonoscope during the procedure. It may facilitate straightening of colonic loops and hence cecal intubation. The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across endoscopists of all levels of experience by making use of the newly developed Endoscopy Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan. The investigators propose to conduct a prospective randomized controlled trial to compare the caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance. Colonoscopies performed by endoscopists with different level of experience will be randomized to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient controlled sedation (PCS) containing propofol and alfentanil will be given to all patients. The investigators hypothesize that UPD-3 guided colonoscopy is associated with high caecal intubation rate (complete colonoscopy), shorter time to caecum, less patient pain and lower sedative medication requirement. A high caecal intubation rate facilitates a reliable colonoscopy screening. Decreased colonic looping and shorter time to caecum may reduce patient discomfort during the procedure. It may also facilitate learning and acquiring the skill of colonoscopy in trainees.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedSeptember 14, 2011
September 1, 2011
1 year
June 20, 2011
September 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
caecal intubation rate
Caeal intubation is the landmark for complete colonoscopy. Caecal intubation would be documented after each procedure. The caecal intubation rate with or without UPD guidance would be compared. The result would provide information whether the UPD device can faciliate complete colonoscopy.
10minutes in average after starting the procedure
Secondary Outcomes (1)
Caecal intubation time
10 minutes in average after starting the procedure
Study Arms (2)
UPD guided group
EXPERIMENTALBoth the colonoscopist and assistant will be viewing the imager screen during the whole procedure.
non-UPD guided group
NO INTERVENTIONConventional colonoscopy would be done without image guidance.
Interventions
A real time, three-dimensional image and position of the colonoscope would be provided to the endoscopist during the procedure.
Eligibility Criteria
You may qualify if:
- Aged 18 years or above
- American Society of Anaesthesiologist (ASA) grading I-III
- Scheduled for elective colonoscopy
You may not qualify if:
- Previous colonic resection
- Refuse to consent to participate
- History of allergy to propofol or alfentanil
- Has a pacemaker in situ
- Pregnant lady
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hong Kong, China
Prince of Wales Hospital
Hong Kong, Hong Kong, China
Related Publications (2)
Shah SG, Brooker JC, Thapar C, Suzuki N, Williams CB, Saunders BP. Effect of magnetic endoscope imaging on patient tolerance and sedation requirements during colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2002 Jun;55(7):832-7. doi: 10.1067/mge.2002.124097.
PMID: 12024136BACKGROUNDShah SG, Brooker JC, Williams CB, Thapar C, Saunders BP. Effect of magnetic endoscope imaging on colonoscopy performance: a randomised controlled trial. Lancet. 2000 Nov 18;356(9243):1718-22. doi: 10.1016/S0140-6736(00)03205-0.
PMID: 11095259BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie SF Hon, MD
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate consultant
Study Record Dates
First Submitted
June 20, 2011
First Posted
September 14, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
September 14, 2011
Record last verified: 2011-09